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Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University of Puerto Rico
Sponsor:
Information provided by:
University of Puerto Rico
ClinicalTrials.gov Identifier:
NCT00927485
First received: June 24, 2009
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.

Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.


Condition Intervention
Familial Adenomatous Polyposis
Drug: Calcumin (Curcumin)
Other: Risk Factor Questionnaire
Other: Blood samples
Other: Biopsies (Sigmoidoscopy)
Other: Biopsies (Upper endoscopy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

Resource links provided by NLM:


Further study details as provided by University of Puerto Rico:

Primary Outcome Measures:
  • To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2007
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curcumin
Curcumin
Drug: Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Name: Curcumin
Other: Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Other: Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
Other: Biopsies (Sigmoidoscopy)
Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.
Other: Biopsies (Upper endoscopy)
Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.
Placebo Comparator: Placebo
Placebo (sugar pills)
Drug: Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Name: Curcumin
Other: Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
Other: Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
Other: Biopsies (Sigmoidoscopy)
Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.
Other: Biopsies (Upper endoscopy)
Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Detailed Description:

Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21-85 years with FAP (with an intact colon or who have had surgery)

Exclusion Criteria:

  • Mentally incompetent
  • Female patients of childbearing age not on effective birth control
  • Patients with WBC < 3,500/ml, platelet count < 100,000/ml, BUN > 25mg%, creatinine > 1.5mg%
  • Patients unable to stop NSAIDS or aspirin use for the duration of the study
  • Malignancy other than nonmelanoma skin cancer
  • Active bacterial infection
  • Patients with GERD (Gastro esophageal reflux disease)
  • Patients with a history of peptic (stomach or duodenal) ulcer disease
  • Patients on Warfarin or anti-platelet drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927485

Contacts
Contact: Marcia R. Cruz-Correa, MD, PhD 787-772-8300 ext 1214 marcia.cruz1@upr.edu
Contact: Jessica Hernandez, MS 787-360-8917 jessica.hernandez8@upr.edu

Locations
Puerto Rico
University of Puerto Rico Comprehensive Cancer Center Recruiting
San Juan, Puerto Rico, 00936
Contact: Marcia R. Cruz-Correa, MD, PhD    787-772-8300 ext 1214    marcia.cruz1@upr.edu   
Contact: Jessica Hernandez, MS    787-360-8917    jessica.hernandez8@upr.edu   
Principal Investigator: Marcia R. Cruz-Correa, MD, PhD         
Sub-Investigator: Priscilla Magno, MD         
Sponsors and Collaborators
University of Puerto Rico
Investigators
Principal Investigator: Marcia R. Cruz-Correa, MD. PhD University of Puerto Rico
  More Information

No publications provided

Responsible Party: Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00927485     History of Changes
Other Study ID Numbers: Protocol A2210108-UPR
Study First Received: June 24, 2009
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Puerto Rico:
Familial Adenomatous Polyposis (FAP)
Curcumin
Colorectal polyps
Duodenal polyps

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenoma
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Curcumin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014